1. To identify the mechanisms of factor V depletion in an in vitro model of TIC2. To evaluate the effect of FV supplementation either alone or in combination with other coagulation factors in in vitro coagulation tests
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objective 1
In vitro: what are the factors related to factor V depletion in trauma-induced
coagulopathy
Objective 2:
In vitro: whether factor V supplementation either alone or in combination with
other factors (PCC and/or fibrinogen) is associated with improvement in clot
build-up determined by ROTEM
Secondary outcome
In vitro coagulation will be assessed through multiple methods, for example:
- ROTEM
- Thrombin generation assay
- Platelet function (aggregometry, flow cytometry, adhesion under flow)
- Plasma coagulation proteins
- Blood group, Hb/HCT, platelet count
Background summary
Severely injured trauma patients present in 40% of cases with a trauma-induced
coagulopathy (TIC), composed of severe platelet dysfunction, coagulation factor
consumption and hyperfibrino(geno)lysis. It has been shown that factor V among
other factors become significantly depleted after trauma. Current treatments
include tranexamic acid (antifbrinolytic), transfusion of plasma, platelets and
red blood cells in a ratio mimicking the composition of the lost blood,
fibrinogen suppletion, and in specific centres prothrombin complex (II, (VII),
IX, X). In animal models supplementation of factor V improves TIC and
mortality. Our hypothesis is that supplementation of factor V either alone or
in combination with other factors (PCC and/or fibrinogen concentrate) will
improve coagulation in an in vitro model of TIC.
Study objective
1. To identify the mechanisms of factor V depletion in an in vitro model of TIC
2. To evaluate the effect of FV supplementation either alone or in combination
with other coagulation factors in in vitro coagulation tests
Study design
Type of study: healthy volunteer observational study
We will draw whole blood from 12 male volunteers (age 18-35) at one timepoint.
Volunteers will be screened beforehand whether they can participate in this
study. Screening will consist of a medical history and current medication use.
A qualified and certified person for performing vena puncture will draw blood.
Blood will be incubated under various conditions.
Study burden and risks
Benefits: none.
The risks and burden of this study are deemed minor, as venepuncture is a
routine procedure in every hospital.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Male
- Age 18-35
Exclusion criteria
-Participation in a scientific intervention study in the last 3 months
-No informed consent
-History of coagulation disorders
-Active use of prescription medication
-Use of anticoagulant medication, including aspirin
-History of liver disease
-History of chronic transmittable disease
-History of alcohol, smoking or drug abuse
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82402.018.22 |